ManufacturingMHRA Approves UK Plasma Manufacturing for Five High-Priority Medicines MHRA Approves UK Plasma Manufacturing for Five High-Priority Medicines Read Post »
Health Tidings Mergers & AcquisitionsSino Biopharma Secures China Rights to GSK’s Trelegy and Anoro Sino Biopharma Secures China Rights to GSK’s Trelegy and Anoro Read Post »
Health TidingsFDA Issues Complete Response Letter for Elevar’s Rivoceranib Plus Cam... FDA Issues Complete Response Letter for Elevar’s Rivoceranib Plus Cam... Read Post »
Health TidingsSino Files TQB3454 NDA in China for IDH1-Mutant Biliary Tract Cancer Sino Files TQB3454 NDA in China for IDH1-Mutant Biliary Tract Cancer Read Post »
Health TidingsArialys Therapeutics Receives FDA Fast Track Designation for ART5803 in Ant... Arialys Therapeutics Receives FDA Fast Track Designation for ART5803 in Ant... Read Post »
Health TidingsOrelabrutinib Becomes First BTK Inhibitor to Show Clinical Efficacy in Lupu... Orelabrutinib Becomes First BTK Inhibitor to Show Clinical Efficacy in Lupu... Read Post »
Health Tidings Mergers & AcquisitionsSerum Institute, DNDi Advance VIS513 Into Global Phase III Dengue Trial Serum Institute, DNDi Advance VIS513 Into Global Phase III Dengue Trial Read Post »
Health TidingsSaol Resubmits FDA Application for SL1009 in Rare Pediatric Mitochondrial D... Saol Resubmits FDA Application for SL1009 in Rare Pediatric Mitochondrial D... Read Post »
GenericsFDA Accepts Amneal and Adalvo ANDAs for Generic Tirzepatide Autoinjectors FDA Accepts Amneal and Adalvo ANDAs for Generic Tirzepatide Autoinjectors Read Post »
Health Tidings Mergers & AcquisitionsTeva Secures Global Rights to Polpharma Biologics’ Proposed Biosimilar to... Teva Secures Global Rights to Polpharma Biologics’ Proposed Biosimilar to... Read Post »
Health Tidings Mergers & AcquisitionsBayer Launches Clinical Trials Alliance With CU Anschutz Bayer Launches Clinical Trials Alliance With CU Anschutz Read Post »
GenericsTeva, Samsung Bioepis Partner to Commercialize OPUVIZ Aflibercept Biosimila... Teva, Samsung Bioepis Partner to Commercialize OPUVIZ Aflibercept Biosimila... Read Post »
Health TidingsAllotera Secures $35M to Advance Pivotal Allogeneic CAR‑T Sofi‑cel in T... Allotera Secures $35M to Advance Pivotal Allogeneic CAR‑T Sofi‑cel in T... Read Post »
Health TidingsMerck Secures FDA Breakthrough Therapy Designation for Enpatoran in Lupus P... Merck Secures FDA Breakthrough Therapy Designation for Enpatoran in Lupus P... Read Post »
Health TidingsGrünenthal Receives FDA Orphan Drug and Rare Pediatric Disease Designation... Grünenthal Receives FDA Orphan Drug and Rare Pediatric Disease Designation... Read Post »
Health TidingsArcutis’ ZORYVE Cream sNDA Accepted by FDA for Infants with Atopic Dermat... Arcutis’ ZORYVE Cream sNDA Accepted by FDA for Infants with Atopic Dermat... Read Post »
Health Tidings Mergers & AcquisitionsSino Biopharmaceutical Licenses COPD Candidate TQC3721 to AstraZeneca in Up... Sino Biopharmaceutical Licenses COPD Candidate TQC3721 to AstraZeneca in Up... Read Post »
Health TidingsImmunome’s Varegacestat NDA Accepted by FDA for Desmoid Tumors Immunome’s Varegacestat NDA Accepted by FDA for Desmoid Tumors Read Post »
Health Tidings Mergers & AcquisitionsChemomab, Scipher Merge to Advance Nebokitug in Rheumatoid Arthritis Chemomab, Scipher Merge to Advance Nebokitug in Rheumatoid Arthritis Read Post »
Health TidingsFDA Aligns With OKYO’s NEPTUNE Phase 3 Trial of Urcosimod in Neuropathic ... FDA Aligns With OKYO’s NEPTUNE Phase 3 Trial of Urcosimod in Neuropathic ... Read Post »
Health TidingsVanda’s VCA-894A Receives FDA Rare Pediatric Disease Designation for Ultr... Vanda’s VCA-894A Receives FDA Rare Pediatric Disease Designation for Ultr... Read Post »
Health TidingsAgios’ Mitapivat Gains FDA Priority Review for Sickle Cell Disease Agios’ Mitapivat Gains FDA Priority Review for Sickle Cell Disease Read Post »
Health TidingsAxsome Moves Solriamfetol into Late-Stage Trial for Children with ADHD Axsome Moves Solriamfetol into Late-Stage Trial for Children with ADHD Read Post »
Health Tidings Mergers & AcquisitionsPraxis Partners with Remagine Labs to Develop Transdermal Patch for Ulixaca... Praxis Partners with Remagine Labs to Develop Transdermal Patch for Ulixaca... Read Post »
Health TidingsFDA Confirms Phase 3 Path for Alterity’s ATH434 in Multiple System Atroph... FDA Confirms Phase 3 Path for Alterity’s ATH434 in Multiple System Atroph... Read Post »
Health TidingsMeiraGTx Wins Up to $400 Million Funding for Gene Therapy Pipeline MeiraGTx Wins Up to $400 Million Funding for Gene Therapy Pipeline Read Post »
Health TidingsRevolution Medicines Advances Daraxonrasib Toward Europe After EMA Starts P... Revolution Medicines Advances Daraxonrasib Toward Europe After EMA Starts P... Read Post »
Health TidingsInsilico Medicine Advances AI-Discovered Rentosertib into Phase III Trial f... Insilico Medicine Advances AI-Discovered Rentosertib into Phase III Trial f... Read Post »
Health TidingsNanoViricides Advances NV-387 Toward Phase II Trial for Bundibugyo Ebola in... NanoViricides Advances NV-387 Toward Phase II Trial for Bundibugyo Ebola in... Read Post »
Health TidingsChina Accepts Astellas’ PADCEV Plus Keytruda Filing for Muscle-Invasi... China Accepts Astellas’ PADCEV Plus Keytruda Filing for Muscle-Invasi... Read Post »
Health TidingsFDA Accepts Organogenesis’ ReNu® BLA for Symptomatic Knee Osteoarthr... FDA Accepts Organogenesis’ ReNu® BLA for Symptomatic Knee Osteoarthr... Read Post »
Health Tidings Mergers & AcquisitionsVertex to Acquire Crinetics for $10 Billion, Adding PALSONIFY and Phase 3 A... Vertex to Acquire Crinetics for $10 Billion, Adding PALSONIFY and Phase 3 A... Read Post »
GenericsGlenmark Launches Generic Olanzapine for Injection in the US, Expanding Ins... Glenmark Launches Generic Olanzapine for Injection in the US, Expanding Ins... Read Post »
Health Tidings Mergers & AcquisitionsAstex Signs Breast Cancer Drug Discovery Deal with Genentech Astex Signs Breast Cancer Drug Discovery Deal with Genentech Read Post »
Health TidingsImmuron Engages Pullan Consulting to Drive IMM-529 Commercial Partnership Immuron Engages Pullan Consulting to Drive IMM-529 Commercial Partnership Read Post »
Health TidingsCelea Raises $180 Million to Launch Phase 3 SURPASS-IPF Trial of Deupirfeni... Celea Raises $180 Million to Launch Phase 3 SURPASS-IPF Trial of Deupirfeni... Read Post »
Health TidingsAscletis Files Dual FDA INDs for Ultra‑Long‑Acting Obesity Therapies Ta... Ascletis Files Dual FDA INDs for Ultra‑Long‑Acting Obesity Therapies Ta... Read Post »
Health Tidings Mergers & AcquisitionsNovartis Acquires Myricx Bio to Advance Novel ADC Payload Technology Novartis Acquires Myricx Bio to Advance Novel ADC Payload Technology Read Post »
Health TidingsMHRA Calls for Faster Regulation to Accelerate Medical Innovation MHRA Calls for Faster Regulation to Accelerate Medical Innovation Read Post »
Health TidingsNewron Maps FDA Path Forward for Evenamide Phase 3 Trial Newron Maps FDA Path Forward for Evenamide Phase 3 Trial Read Post »
Health TidingsCincinnati Children’s Phase 2 Trial Shows WRSs2 Shigella Vaccine Achi... Cincinnati Children’s Phase 2 Trial Shows WRSs2 Shigella Vaccine Achi... Read Post »
Health TidingsNature Publication Strengthens Arcus’ Casdatifan Program in Advanced ... Nature Publication Strengthens Arcus’ Casdatifan Program in Advanced ... Read Post »
Health TidingsFDA Issues Complete Response Letter to Ascelia Pharma’s Orviglance ND... FDA Issues Complete Response Letter to Ascelia Pharma’s Orviglance ND... Read Post »
Health Tidings Mergers & AcquisitionsArcturus Therapeutics Announces Strategic Collaboration with Thermo Fisher ... Arcturus Therapeutics Announces Strategic Collaboration with Thermo Fisher ... Read Post »
GenericsEMA Expands Lupin’s NaMuscla Approval to Include Children with Non-Dystro... EMA Expands Lupin’s NaMuscla Approval to Include Children with Non-Dystro... Read Post »
Health Tidings Mergers & AcquisitionsTakeda Partners With Insilico Medicine in AI Drug Discovery Deal Worth Up t... Takeda Partners With Insilico Medicine in AI Drug Discovery Deal Worth Up t... Read Post »
Health Tidings Regulatory & Health Policy Women & Child HealthEMA Moves to Embed Women’s Health Across Europe’s Medicines Reg... EMA Moves to Embed Women’s Health Across Europe’s Medicines Reg... Read Post »
Health Tidings Mergers & AcquisitionsUnited Therapeutics Acquires Thymmune to Expand T-Cell Regeneration Researc... United Therapeutics Acquires Thymmune to Expand T-Cell Regeneration Researc... Read Post »
Health TidingsJCO Study Supports FDA Approval of BIZENGRI in NRG1+ Cholangiocarcinoma JCO Study Supports FDA Approval of BIZENGRI in NRG1+ Cholangiocarcinoma Read Post »
Health TidingsMHRA Starts Evaluation of Eisai’s Lemborexant for Adult Insomnia MHRA Starts Evaluation of Eisai’s Lemborexant for Adult Insomnia Read Post »
